BUDESONIDE – Capsules

Budesonide (Entocort EC) is used to treat Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever). Budesonide (Tarpeyo) is used to decrease protein in the urine in patients with primary immunoglobulin A nephropathy (kidney disease that occurs in some people when too much immunoglobin A builds up in the kidney, causing inflammation). Budesonide is in a class of medications called corticosteroids. It works by decreasing inflammation (swelling) in the digestive tract of people who have Crohn’s disease or in the kidney of people with nephropathy.

Budesonide comes as a capsule to take by mouth. It is usually taken once a day in the morning. Take budesonide at around the same time every day. Budesonide (Tarpeyo) should be taken at least one hour before a meal. Your doctor will tell you how long to take budesonide. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take budesonide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them. If you are unable to swallow the budesonide (Entocort EC) capsules whole, the capsules may be opened and sprinkled on a tablespoonful of apple sauce, mixed well and swallowed whole with no chewing within 30 minutes of mixing. The applesauce mixture should be followed by a full glass of water.

Budesonide may help control your symptoms, but it will not cure your condition. Your doctor will watch you carefully to see how well budesonide works for you. If your symptoms are controlled, your doctor may decrease your dose of budesonide. After your symptoms have been controlled for 3 months, your doctor may slowly decrease your dose and then stop treating you with this medication. It is important to tell your doctor how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking budesonide,

• tell your doctor and pharmacist if you are allergic to budesonide, or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: cyclosporine, erythromycin, ketoconazole, indinavir, itraconazole, ritonavir, and saquinavir. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with budesonide, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you or anyone in your family has had diabetes (high blood sugar) or glaucoma, or if you have tuberculosis, high blood pressure, osteoporosis (a condition in which the bones become thin and weak and break easily), stomach ulcer, cataracts, or liver disease.
• tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, or are breastfeeding. If you become pregnant while taking budesonide, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking budesonide.
• tell your doctor if you have never had chicken pox or measles and you have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chicken pox or measles. If you are exposed to one of these infections or if you develop symptoms of one of these infections, call your doctor right away. You may need treatment to protect yourself from these infections.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Budesonide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dizziness
• runny nose, sneezing, coughing
• nausea
• indigestion
• abdominal pain
• dry, itchy skin
• gas
• vomiting
• fatigue
• back pain
• pain
• muscle cramps

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• itching
• skin rash
• fever
• swelling of the face and neck
• difficulty breathing
• severe headache
• changes in vision
• acne
• bruising
• swelling of the legs or arms
• fatty pad or hump between your shoulders
• pink or purple stretch marks on the skin of your stomach, thighs, breasts or arms

Budesonide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication or if your symptoms get worse.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.

In case of overdose, call the poison control helpline at 1-800-222-1222.  If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking budesonide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.